Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia

Launched by M.D. ANDERSON CANCER CENTER · Jun 10, 2011

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with acute lymphoblastic leukemia (ALL), a type of blood cancer. The study is looking at a combination of a targeted therapy called inotuzumab ozogamicin, which helps the immune system attack cancer cells, along with standard chemotherapy drugs. Researchers want to understand how well this combination works and what side effects it may cause. This trial is open to adults aged 18 and older, particularly those who are 60 and above, and includes patients with various forms of ALL, including those who may not be able to tolerate intensive chemotherapy due to other health issues.

If you participate in this trial, you will receive the combination treatment and be monitored closely for how well it works and any side effects you may experience. Before joining, you’ll need to meet certain health criteria, such as having adequate liver and kidney function and not having active heart problems. The goal is to find a safer and more effective way to treat ALL, so if you or a loved one are eligible, this could be an opportunity to access new treatment options while contributing to important research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients age 60 years or older with previously untreated ALL pre-B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL Minimal prior therapy (less than 1 week of steroids, vincristine, and/or 1 dose of anthracycline or alkylating agents) are allowed.
• • 2. Patients unfit ≥ 18 - \< 60 years of age with previously untreated ALL pre- B, Philadelphia chromosome (Ph-) negative or (Ph+) positive ALL (includes patients initiated on first cycle of hyper-CVAD before cytogenetics known. These patients could have received one or two cycles of chemotherapy with or without other TKIs and still eligible.
• These patients are defined as having at least one of the below comorbidities:
• • 1. ECOG performance status ≥ 2
• • 2. Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤ 50%, or chronic stable angina)
• • 3. Severe pulmonary disorder (e.g., DLCO ≤ 65% or FEV1 ≤ 65%)
• • 4. Creatinine clearance \< 45 mL/min, and
• • 5. Hepatic disorder with total bilirubin \> 1.5 x upper limit of normal
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• • 1. If they achieved CR, they are assessable only for event-free and overall survival, or
• • 2. If they failed to achieve CR, they are assessable for CR, event-free, and overall survival
• • 3. Patients age 60 years and older unfit for intensive chemotherapy with one or more comorbidities (e.g., renal insufficiency, heart disease, cardio-vascular disease, uncontrolled hypertension, diabetes, respiratory problems, among others) and a PS of ≥ 1. All ages of Jehovah's witness are eligible.
• • 4. Zubrod performance status 0-3.
• • 5. Adequate liver function (bilirubin \< 1.95 mg/dL and SGPT or SGOT \< 3 x upper limit of normal \[ULN\], unless considered due to tumor), and renal function (estimated creatinine clearance ≥50 mL/min/1.73 m2). Even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is \< 2.6 mg/dL and creatinine \< 3 mg/dL.
• • 6. Provision of written informed consent.
• • 7. Patients in first remission are eligible.
• • 8. Patients with refractory-relapsed ALL, Burkitt lymphoma, Burkitt-like lymphoma with 11q aberration, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma not otherwise specified with marrow involvementBof any age are eligible.
• Exclusion Criteria:
• • 1. Newly diagnosed Burkitt's Leukemia or Lymphoma, T-cell ALL or lymphoblastic lymphoma.
• • 2. Patient with active heart disease (NYHA class \> 3 as assessed by history and physical examination).
• • 3. Patients with a cardiac ejection fraction (as measured by either MUGA or echocardiogram) \< 40% are excluded.
• • 4. Patients with active hepatitis are excluded.
• • 5. Pregnant or breast-feeding women are excluded.